Cancer Drug May Not Get A Chance Due to Lack of Patent

theshowmecanuck writes to mention that in a recent study, researchers at the University of Alberta Department of Medicine have shown that an existing small, relatively non-toxic molecule, dichloroacetate (DCA), causes regression in several different cancers. From the article: "But there's a catch: the drug isn't patented, and pharmaceutical companies may not be interested in funding further research if the treatment won't make them a profit. In findings that 'astounded' the researchers, the molecule known as DCA was shown to shrink lung, breast and brain tumors in both animal and human tissue experiments."

Am I missing something?

[Anonymous Coward]

If this *REALLY* works, wouldn't people be willing to pay for it?

If people are willing to pay for it, how come somebody isn't willing to profit from it?

Better, more informative article

[Anonymous Coward]

here [newscientist.com]

-mcgrew (my computer is broken):

May not matter.

[Irvu]

Even if the companies do turn it down they will get a further crack at it. Courtesy of the Byah-Dole act most publicly funded research (especially drug research) in the U.S. can later be "bought" by private companies who may then claim "intellectual property" on the fruits of the public's labors. It is this law that allows both AZT and Viagra (developed with funding from the National Institutes of Health) to be considered "private" property and for the companies to charge the people who invested in their development for their use.

The practical upshot of this is that if the drug does go to the universities to be developed it would be following the normal track of most medical research. And if any patentability (say on dosage levels) does show up the companies can always buy it then.

Not in the "West"

[NMerriam]

Cuba has a large, thriving and internationally recognized cutting-edge pharmaceutical and biomedical research industry. They specialize in developing and distributing drugs to the 99% of planet Earth that can't afford $5/day to get harder erections. They generally research based on the commonality and severity of particular diseases, and then try to find exceptionally low-cost ways to solve them better. Ironically enough, it's quite profitable since selling tens of millions of pills to entire continents at 1% profit can add up pretty quickly.

Re:This just in...

[Mr. Underbridge]

So if this medecine is so wonderful, and developing medecines for profit is so evil, why doesn't this University start mass-producing this medecine and giving it away for free?

For one, it would be illegal since the thing isn't FDA approved. And what does it take to get FDA approved, you ask? Years of studies and many millions of dollars. See many of the other posts on the topic, I'll not repeat them, but the basic point is that they'd have no hope of recouping their investment simply because tons of other companies would drive the price of the drug through the floor.

0.o

[Muad'Dib129]

I am not surprised. I watched my mother in law die of lung cancer a few years ago. Her best (insurance-funded, of course) option was radiation & chemotherapy. A few months ago (July-August), I watched my father go through practically the same thing. Once again, his best (and also insurance-funded) option was radiation & chemotherapy. One bill I saw, that he had to fork out $225 for (co-pay for it being over $20k), was almost $21,000. Why is there not a cure and treatments are our best option? The fat ass American medical industry and the pharmaceutical industry can charge 10K per session to the Insurance Industry, who just plain rips off the American people. It would be such a wonderful irony to see something that isn't patented become a cure...then it would be available to EVERY F*CK*NG PERSON who could throw down a few bucks for the cure, instead of having to rely on the bullshit fat ass Insurance, Medical and Pharmaceutical industries to give us these bullshit treatments that prolong the agony. There would be fierce competition for sales of this cure, therefore making the price of it affordable without the necessity for the Insurance company to intervene.

Re:Funny

[Dr Caleb]

It's not a broken system. On my local news (Edmonton, home of the UofA) they are specifically NOT including drug companies in funding the trials, because they want the drug to be cheap.

FTA:

"A small, non-toxic molecule may soon be available as an inexpensive treatment for many forms of cancer, including lung, breast and brain tumours, say University of Alberta researchers."

Sir Frederick Banting, (another Canadian) did the same thing with his patent for Insulin, so that drug companies would never have a monopoly on something needed for people to live.

Re:Oh dear lord, here come the loonies.

[Anonymous Coward]

Go ahead... name a few significant drugs discovered/invented in Socialist countries.
Meningitis B vaccine, from Cuba. In fact, Cuba has a world class biomedical industry [yale.edu].

Re:Generic drug manufacturers

[jfengel]

I was not aware that the drug is already in use. If it is, you don't actually have to do anything: you can just get doctors to prescribe it off-label. (That's in the US; given that this is Alberta I can't say what the rules are.) You'd end up doing a Phase IV trial, which can be a lot cheaper if you can just get doctors to send in data.

Re:Moo

[Andy Dodd]

Or you can patent one of the production processes for it.

Someone mentioned the inventor of insulin trying to ensure a "no-monopoly" situation, but since the advent of human insulin produced by genetically engineered bacteria (as opposed to from the pancreas of slaughtered cows/pigs), a select few companies (Eli Lilly and Novo Nordisk and that's about it with one exception) have dominated the insulin market since the 1970s (Insulin was discovered in the early 1920s, by the way) due to patents on:

Methods of producing insulin (specifically recombinant DNA origin insulins)
Methods of tweaking insulin to be absorbed/used by the body over a longer period of time by adding stuff to the injected mixture (Lente, Ultralente, NPH, etc)
Methods of producing insulin with "faster than natural" activity profiles by tweaking the molecular structure itself (Humalog and Novolog)
Methods of producing insulin with extremely long "peakless" activity profiles by a combination of the above two techniques (Lantus and Levemir) - BTW this is where the one exception to the Lilly/Nordisk dominance is. Lantus is made by Aventis.

From one "unpatented" drug that according to this article will not have an interest from big pharma, history shows that global market dominance can still be established. I have a feeling drug companies right and left will be racing to tweak this new drug to make a better version or better production process (which happens to be patentable).

Re:Private enterprises won't develop the cure?

[Abcd1234]

this is something that kills tumors in-vitro,

Actually, according to this more thorough article [newscientist.com], the drug has also proven effective is mouse models.

Granted, this still isn't the same as a human trial, but it's a far cry from simply killing cancer in a petri dish.

As for the notion that the unwillingness to develop a drug in the absence of patent protection somehow is an argument against patents

Actually, it's more of an argument against privately funded drug development, as it's pretty clear that an unpatentable drug, no matter how effective, isn't useful to a company who's sole purpose is to make money.

Re:It's not as if...

[Abcd1234]

If somebody wants to sell this to treat cancer, the FDA is going to require 800 million dollars worth of Phase I, II, and III clinical trials before it allows the claim.

Not AFAIK. My understanding is that the FDA will fasttrack an already approved drug (such as this one) for alternative uses. Since safety is already proven, the only thing necessary is efficacy trials (so far as I know).

Fortunately, this makes it far more likely that a non-profit (or the government, who is obviously interested in lowering healthcare costs) could pick up the table to fund the research.

Re:Generic drug manufacturers

[steelfood]

I believe this compound has been in use for a long time, albeit for other higher-level purposes. This is merely a different application of the same compound. It's almost like taking asprin for heart disease instead of pain. Since the compound already exists in a FDA approved form, why then would the researchers have to go through the same trouble again? At the very least, they'd be able to cite the previous studies done for FDA approval, and that should speed up the process considerably.

Given this, I'd think it'd be easy for companies that make generics to start selling this.

I think any funding would be going into testing to further medical knowledge rather than to attain any form of approval for use.

Re:Am I missing something?

[stormcoder]

Actually, if you read the article (I know bizarre), you would have know that it is already and FDA approved drug and is actively prescribed. It has some side effects but nothing horrible. Since it is already approved, getting it cleared for use in a an additional capacity is much easier since it has been proven safe for human use. The only thing that needs to be proved is effecacy.

Re:Horsefeathers ...

[Jerry Rivers]

Maybe you should read your own references. To wit:

"However, concern about DCA toxicity is predicated mainly on data obtained in inbred rodent strains administered DCA at doses thousands of times higher than those to which humans are usually exposed."

And

"As a medicinal, DCA is generally well tolerated and stimulates the activity of the mitochondrial pyruvate dehydrogenase enzyme complex, resulting in increased oxidation of glucose and lactate and an amelioration of lactic acidosis."

As for your other "source" (if one can call About.com a reliable source), the last sentence is telling: "The findings show that this side effect of DCA outweighs any potential beneficial effect of the medication in treating MELAS." In other words, DCA isn't good for people with the exceedingly rare MELAS SYNDROME.

Re:Generic drug manufacturers

[Jeff DeMaagd]

I heard about the Vioxx situation on NPR's Science Friday, that it was a confluence of bad events. The drug had a very narrow group of indications but was practically advertised as a general-use product. There are suggestions that off-label prescriptions were strongly recommended, carelessly using it to treat illnesses for which it was not tested. In some situations, having the drug is actually better than not having it (a debilitating painful illness vs a very small risk of death), but there apparently is no good way to restrict the use so that only the people that really do desperately need it will get it.

It's basically a case of too much of a good thing. IIRC, there are were suggestions of allowing restricted use but I don't remember what the deal is.

Re:Not in the "West"

[RonBurk]

And yet, there is the disturbing case of policosanol (just buy some Cuban sugar cane to make it!). Policosanol has the disturbing property that it seems to treat high cholesterol when tested by Cuban-funded studies, but not when tested with non-Cuban dollars.

Also disturbing is the fact that the Cubans discovered a new use for policosanol (increasing BMD for post-menopausal women) at just about exactly the time the cholesterol claim was being shot down by a large study.

Let's not all sign up for the Cuban model of drug development just yet.

In America, in Europe, in Cuba, and (I bet) in Timbuktu, one unfortunately always has to ask "who profits" when evaluating the claims made for any given drug.

Re:Are you trying to troll me?

[Dr Caleb]

Well, then he's trolling. 'Nationalized Healthcare' means we pay for it through our taxes, so price does matter. Many cancer treatments can run $12,000 a month, and are not covered by many provincial healthcare plans.

There are many things we must pay for, out of pocket. Perscription drugs and non-approved cancer treatments are two of them.

Re:Are you trying to troll me?

[dryeo]

Actually the average Canadian still has to pay for their drugs. Exceptions include people on income assistance, pensioners and perhaps others.

Jackass

[Cadallin]

If'd you actually bothered to read the article on Wikipedia on Insulin, you'd have learned that Frederick Banting was in fact the first person to extract the active agent from the islets of langerhans in the pancreas. He didn't know what it was (insulin was identified as the active ingredient of the extract some time later) but Banting was responsible for developing the first effective treatment for diabetes mellitus and he shared the 1923 Nobel Prize in Medicine for the Discovery of insulin with J. R. Macleod (who identified the insulin molecule as the active ingredient).

Re:May not matter.

[FallLine]

Reducing the duration of patents would solve this particular problem. There would be motivation to get the drug on the market quickly and make one's profits. If the durations were decreased, then drug profits would be decreased, which means that the drug companies would have even more motivation to produce more medications in the hope of getting a major hit.

This is a total non-sequitur.

First, drug companies have a huge incentive to rush a drug to market once they believe it is safe and effective. They've invested hundreds of millions of dollars -- they're not going to delay their ability to reap the profits unnecessarily. Even if you assume it wouldn't impact their patent life on market, the shareholders and management are highly motivated to make it happen ASAP.

Second, the patent duration is relatively fixed in practice and they maximize their time on market with patent protection by getting it there more quickly. The absolute most they can gain is 5 years for the testing and regulatory review process, but no more than 14 years post-approval, and the FDA reduces time spent in testing (non-agency review) by half. So if they drag a clinical trial out for 2 years longer than necessary, they'd lose 1 year effectively. Most drugs have less 10 years on market before the patent expires.

Third, drug companies can't make "too much" money for shareholders. They want to maximize their investment. If they've identified a drug that might worthwhile, they're going to patent it ASAP to prevent their competitors from beating them to the punch. Once they've done that the clock starts counting against them and they would be stupid to sit around on something that they have good cause to believe would work.

Re:Am I missing something?

[sp3d2orbit]

The drug companies would like us to believe that patents are necessary to bring new drugs to market. Those who "drank the kool-aid" claim that without patents generic drugs would make drug research unprofitable.

What is profitable?

Pfizer [google.com] pulled in $51.2 billion in 2006 with $8 billion in profits.
Merck [google.com] wasn't as "profitable", with only $4.6 billion in profits on $22 billion total income.
The top 10 drug makers [google.com] are worth $1.125 trillion and made $50 billion.

But, what these numbers don't show is that there are barely more than 10 major players making any significant money in drugs. Is that because there is so little money to be made? A mere $50 billion?

I can't figure out how a free market would allocate so much wealth into so few hands. Unless the market wasn't free to start with.

Drug companies use patents to subdivide the treatable medical domain into discrete markets that can be monopolized or duopolized so long as the patent stands. It is true that without the patents there would be more generics to compete with. That's not a bad thing.

The drug company who first develops a medicine still has a competitive advantage, even without a patent. They will be first to market. They have the opportunity to define the brand in the eyes of the consumer. Brands like Viagra and Botox have value to the user that a patent doesn't provide.

Drug patents are not really "necessary" to make a profit, but they are necessary to make such huge profits.

Re:Am I missing something?

[Swave An deBwoner]

Here is an interesting article about where the health care money actually goes. Purportedly, about 30% goes to the insurance companies, not to doctors, nurses, pharmaceutical companies, or anyone else actually involved in delivering medical care.

(The article is free, though you have to sign up, for free, with Medscape before getting access to it.)

http://www.medscape.com/viewarticle/508911 [medscape.com]

Up to a point (differs by province)

[Rob Simpson]

In BC everyone has a deductible based on income... for non-seniors who make >$30000/year, when drug costs reach 3% of annual income Pharmacare pays 70%, and when at 4% of annual income Pharmacare pays 100%. (For people on expensive and long-term treatments, there is the option to spread out the deductible cost over the year.) Many "average" people with diabetes or high blood pressure will receive at least some coverage.

Even someone who makes six figures may get their drugs paid for if they are on extremely expensive treatments. There are also other types of coverage, such as pallative and mental health, which will pay 100% with no deductible needed for specific drugs.

Not exactly

[Rob Simpson]

Drug companies could easily afford to sell their meds for less than Canadian prices if they slashed their marketing budgets. The price differences aren't that huge... More importantly, Canadian provincial plans will pay for the cost of the generic drug whose patent has expired, or a new type of drug which has been proven more effective, but if you want an evergreened version that costs three times as much because of the "Type R" sticker slapped on it - you can pay for it.

Lowest Cost Alternative [gov.bc.ca]

Also, consider this from JAMA [ama-assn.org]: "None of the first-line treatment strategies-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel blockers (CCBs), -blockers, and angiotensin receptor blockerswas significantly better than low-dose diuretics for any outcome."

The diuretics they refer to cost about a penny per pill. Some of the other treatments cost more than a dollar per pill.

It's not really a barrier.

[Grendel Drago]

Not really. Botox is approved for muscle spasms, and gabapentin for seizures. The vast majority of uses are off-label; it doesn't seem to have stopped doctors from prescribing the drugs. While I'm sure there are liability concerns, I don't think they're the barrier you make them out to be for prescribing drugs off-label.